FDA Grants Approval to CeloNova Biosciences’ COBRA PzF Stent System March 1, 2017 The stent improves coronary luminal diameter in patients. Read More
At Last: New EU MDR Regulations Near Final Approval March 1, 2017 The European Council is set to vote on the regulations on March 7. Read More
Velano Vascular Gains FDA Clearance for Needle-Free Blood Draw Technology February 28, 2017 Clinicians can now draw blood from indwelling peripheral IV lines. Read More
FDA Clears ViewRay’s MRIdian Linac System February 28, 2017 MRI-guided radiation therapy system to be installed in two U.S. hospitals. Read More
FDA Awards Philips’ ElastQ Imaging Assay Marketing Clearance February 28, 2017 ElastQ Imaging enables simultaneous imaging of tissue and assessment of liver stiffness. Read More
Scopis Wins FDA Clearance and Health Canada MDL Clearance for Its Surgical Navigation System February 28, 2017 The modularity and versatility of this platform also permits interdisciplinary use. Read More
DiaCarta Nabs CE-IVD for its Non-Invasive Colorectal Cancer Test February 27, 2017 The device detects mutations in DNA extracted from solid tumor, plasma or stool samples. Read More
Zimmer Biomet Recalls Shoulder Device February 27, 2017 The shoulder replacements have been fracturing at a higher rate than expected. Read More
FDA Awards Voxello Marketing Clearance for Speech Generation Device February 27, 2017 The device enables patients to control up to three different devices with a single touch. Read More
Philips Gains FDA Marketing Clearance for Intellivue Guardian Solution February 27, 2017 The device helps detect subtle signs of patient deterioration, by measuring heart rate, respiratory rate, posture and detecting falls. Read More
E-QURE's BST Device Receives Marketing Approval in Israel February 24, 2017 BST is treatment for chronic wound care. Read More
FDA Permits Marketing of Phenotest BC Kit to Identify Organisms That Cause Bloodstream Infections February 24, 2017 The test can identify 14 different species of bacteria and two species of yeast that cause infections. Read More